Ophthalmic treatment composition and vehicle for delivery of pharmaceutical substances or therapeutic agents

Abstract

An ophthalmic treatment composition for the treatment of dry eye consists essentially of squalane in an amount by weight of 1% to 100%; and mineral oil in an amount by weight of 0% to 99%. Preferably, the mineral oil is a light mineral oil or mixture of light mineral oils and is present in an amount by weight of 1% to 10%. The composition is effectively devoid of water, preservatives, emulsifiers and dispersing agents. A related ophthalmic treatment composition comprises squalane in an amount by weight of 1% to 99% and mineral oil in an amount by weight of 0% to 99% and at least one hydrophobic or lipophilic pharmaceutical substance in an amount by weight of 0.01% to 5%, effective for treatment of at least one ophthalmic condition.

What is claimed is: 
     
         1 . A method for treating an ophthalmic or per-ocular skin condition in a mammal in need thereof, the method consisting of administering to an eye or surrounding tissues of said mammal in need thereof therapeutically effective amounts of a composition consisting essentially of:
 squalane in an amount of at least 95% volume/volume of the composition, wherein the squalane inhibits dry eye; and   a chemical treatment substance in an amount by weight of 0.01% to 5% of the weight of the entire composition,   the composition being effectively devoid of water, preservatives, emulsifiers and dispersing agents.   
     
     
         2 . The method defined in  claim 1  wherein the ophthalmic or per-ocular skin condition is taken from the group consisting of atopic dermatitis and other adnexal tissue condition, ocular inflammation and eye lid and facial skin disorders, ocular and adnexal and facial allergic and inflammatory skin conditions, ocular and adnexal and facial allergic and inflammatory skin conditions, exposure to UVA or UVB radiation (prophylactic protection), ocular and peri-ocular skin infections, and acne and skin wrinkles. 
     
     
         3 . The method defined in  claim 2  wherein the chemical treatment substance is taken from the group consisting of 0.03% to 0.05% Tacrolimus by weight for pets and humans with atopic dermatitis and other adnexal tissue, 0.3% to 0.5% Loteprednol suspensions by weight for ocular inflammation and eye lid and facial skin disorders, 1% to 2% Hydrocortisone by weight for ocular and adnexal and facial allergic and inflammatory skin conditions, 0.5% to 1.0% Dexamethasone by weight for ocular and adnexal and facial allergic and inflammatory skin conditions, titanium dioxide powder of nanoscale particle size as eye lid sunscreen from UVA rays, zinc oxide as UVB sunscreen, about 3% tobramycin by weight as antibiotic for ocular and peri-ocular skin infections, about 3% bacitracin by weight as antibiotic to eye and peri-ocular tissue, and 3% Cefalexin by weight for ocular and per-ocular antibacterial use, wherein the weight percentage for each member of the group is by weight of the entire composition, and Retin-A in a conventional weight percentage or an amount reduced relative to extant amounts. 
     
     
         4 . The method defined in  claim 1  wherein the chemical treatment substance is a prostaglandin. 
     
     
         5 . The method defined in  claim 1  wherein the chemical treatment substance is taken from the group consisting of Retin-A, titantium dioxide powder and zinc oxide. 
     
     
         6 . A method for treating ocular or peri-ocular tissue in a mammal in need thereof consisting of administering to said mammal in need thereof effective amounts of a composition consisting of squalane, wherein the squalane inhibits dry eye, the composition including squalane in an amount of at least 95% volume/volume, optionally including a mineral oil or mixture of mineral oils and also including a treatment agent or substance, the composition being effectively devoid of water, preservatives, emulsifiers and dispersing agents. 
     
     
         7 . The method defined in  claim 6 , wherein said treatment agent or substance is taken from the group consisting of Tacrolimus, Loteprednol, hydrocortisone Dexamethasone, titanium dioxide powder, zinc oxide, tobramycin, bacitracin, Cefalexin, and Retin-A. 
     
     
         8 . The method defined in  claim 7 , wherein Tacrolimus if present in said composition is in an amount of 0.03% to 0.05% by weight of the entire composition, Loteprednol if present in said composition is in an amount of 0.3% to 0.5% by weight of the entire composition, hydrocortisone if present in said composition is in an amount of 1% to 2% by weight of the entire composition, Dexamethasone if present in said composition is in an amount of 0.5% to 1.0% by weight of the entire composition, tobramycin if present in said composition is in an amount of 0.5% to 1.0% by weight of the entire composition, bacitracin if present in said composition is in an amount of about 3% by weight of the entire composition, Cefalexin if present in said composition is in an amount of about 3% by weight of the entire composition, and Retin-A if present in said composition is in a conventional weight percentage or an amount reduced relative thereto. 
     
     
         9 . The method defined in  claim 6  wherein the administering of said composition comprises topically applying an effective amount thereof to an eye or per-ocular tissue of the mammal. 
     
     
         10 . The method defined in  claim 6  wherein the treatment agent or substance is a prostaglandin. 
     
     
         11 . The method defined in  claim 1  wherein the treatment agent or substance is taken from the group consisting of Retin-A, titantium dioxide powder and zinc oxide. 
     
     
         12 . A method for treating ocular or peri-ocular tissue in a mammal in need thereof consisting of administering to an eye or surrounding tissues of said mammal in need thereof therapeutically effective amounts of a composition consisting essentially of squalane in combination with an amount of a treatment substance taken from the group consisting of 0.03% to 0.05% Tacrolimus by weight for pets and humans with atopic dermatitis and other adnexal tissue, 0.3% to 0.5% Loteprednol suspensions by weight for ocular inflammation and eye lid and facial skin disorders, 1% to 2% Hydrocortisone by weight for ocular and adnexal and facial allergic and inflammatory skin conditions, 0.5% to 1.0% Dexamethasone by weight for ocular and adnexal and facial allergic and inflammatory skin conditions, titanium dioxide powder of nanoscale particle size as eye lid sunscreen from UVA rays, zinc oxide as UVB sunscreen, Retin-A for treatment of acne and skin wrinkles, about 3% tobramycin by weight as antibiotic for ocular and peri-ocular skin infections, about 3% bacitracin by weight as antibiotic to eye and peri-ocular tissue, and 3% Cefalexin by weight for ocular and per-ocular antibacterial use, percentage by weight of the entire composition, the composition including squalane in an amount of at least 80% volume/volume, the composition being effectively devoid of water, preservatives, emulsifiers and dispersing agents. 
     
     
         13 . The method defined in  claim 12  wherein the composition includes mineral oil or mixture of mineral oils in an amount of 1% to 10% volume/volume. 
     
     
         14 . The method defined in  claim 12  wherein the administering of said composition includes applying said composition to an eye or eyelid of said mammal. 
     
     
         15 . The method defined in  claim 12  wherein the composition includes squalane in an amount of at least 95% volume/volume.